Identity
- Trade Name
- Spartan RX CYP2C19 System FDA UDI
- Generic Name
- Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated FDA UDI
- Device Name
- This is Box 1 of 3 of the Spartan RX CYP2C19 Platform. It contains the Spartan RX Analyzer (01004777) and the Spartan RX Barcode Scanner (01003359). FDA UDI
- Model / Reference
- 01004985 FDA UDI
- Description
- This is Box 1 of 3 of the Spartan RX CYP2C19 Platform. It contains the Spartan RX Analyzer (01004777) and the Spartan RX Barcode Scanner (01003359). FDA UDI
Identifiers
- Catalog Number
- 01004985 FDA UDI
- Primary DI / UDI-DI
- 00628055420064 FDA UDI
- FDA Product Code
- NSU FDA UDINTI FDA UDI
- GMDN Term
- Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.2570 FDA UDI862.3360 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated
Spartan RX CYP2C19 System by Spartan Bioscience, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Spartan RX CYP2C19 System — Spartan Bioscience, Inc. · Class II
- Spartan RX CYP2C19 System — Spartan Bioscience, Inc. · Class II
- Spartan RX CYP2C19 System — Spartan Bioscience, Inc. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Spartan Bioscience, Inc.
Sources (1)
- FDA UDI 1f7740f6-6b1d-4ab2-9afa-364b615545f7 34 fields · synced Jun 8, 2026